ong-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel
Phase 1
- Conditions
- Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005521-84-NL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
All subjects who received cilta-cel in a Company-sponsored clinical study are candidates for Study MMY4002. The inclusion criteria for the study are described below:
1. Subjects who have received at least one dose of cilta-cel in a Company-sponsored clinical study.
2. Subjects who have provided informed consent for Study MMY4002.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
No exclusion criteria are applicable in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method